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Babak Mokhlesi - One of the best experts on this subject based on the ideXlab platform.
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adherence to positive airway pressure therapy in Obesity Hypoventilation Syndrome
Sleep Medicine Clinics, 2021Co-Authors: Jeremy Wearn, Bimaje Akpa, Babak MokhlesiAbstract:Because of the prevalence of extreme Obesity in the United States, there has been an increase in prevalence of Obesity Hypoventilation Syndrome (OHS). There is limited information on the characteristics and pattern of positive airway pressure (PAP) adherence in patients with OHS compared with eucapnic patients with obstructive sleep apnea (OSA). This article discusses in detail the impact of PAP therapy on outcomes in patients with OHS, compares adherence between continuous PAP and noninvasive ventilation in OHS, and compares PAP adherence in patients with OHS to patients with moderate to severe OSA enrolled in clinical trials designed to improve CPAP adherence.
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cpap titration failure is not equivalent to long term cpap treatment failure in patients with Obesity Hypoventilation Syndrome a case series
Journal of Clinical Sleep Medicine, 2020Co-Authors: Alejandra Lastra, Juan F Masa, Babak MokhlesiAbstract:Study Objectives:Medium and long-term trials comparing continuous positive airway pressure (CPAP) with noninvasive ventilation in patients with Obesity Hypoventilation Syndrome have shown no differ...
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weight loss interventions as treatment of Obesity Hypoventilation Syndrome a systematic review
Annals of the American Thoracic Society, 2020Co-Authors: Maximiliano Tamae Kakazu, Juan F Masa, Israa Soghier, Jan Brozek, Majid Afshar, Kevin C Wilson, Babak MokhlesiAbstract:Rationale: Obesity Hypoventilation Syndrome (OHS) is an undesirable consequence of Obesity. Weight loss is an important component of management based on clinical rationale, but the evidence supporting weight loss has not been summarized and the optimal approach has not been determined.Objectives: This systematic review informed an international, multidisciplinary panel of experts who had converged to develop a clinical practice guideline on OHS for the American Thoracic Society. The panel asked, "Should a weight loss intervention be performed in patients with OHS?"Methods: Medline, the Cochrane Library, and Embase were searched from January 1946 to March 2019 for studies that assessed weight loss interventions in obese adults with confirmed OHS, suspected OHS, or hypercapnia. The quality of the evidence was appraised using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach.Results: The search identified 2,994 articles. Six studies were selected, including two randomized trials and four nonrandomized studies without a comparator. Sample size ranged from 16 to 63 subjects. The studies found that a comprehensive weight loss program (including motivational counseling, dieting, and exercise) can reduce weight by 6% to 7% but confers no clinically significant effects compared with standard care. Bariatric surgery, on the other hand, is associated with more robust weight loss (15-64.6%, depending on the type of intervention), reduction of obstructive sleep apnea severity (18-44% reduction of the apnea-hypopnea index), and improvement in gas exchange (17-20% reduction in partial pressure of carbon dioxide in the arterial blood), ultimately leading to the resolution of OHS. Moreover, daytime sleepiness and pulmonary artery pressure also improve with significant weight loss. Bariatric surgery is associated with adverse effects in roughly one-fifth of patients, but serious adverse effects are very rare. The level of certainty in the estimated effects was very low for most outcomes.Conclusions: The guideline panel for which the systematic review was performed made a conditional (i.e., weak) recommendation suggesting a weight loss intervention for patients with OHS, targeting a sustained weight loss of 25% to 30% of actual body weight. This recommendation was based on very low-quality evidence. Although the weight loss target is based on the observation that greater weight loss is associated with better outcomes, there is a need for better-quality studies to ascertain the degree of weight loss necessary to achieve improvement in clinically relevant outcomes in patients with OHS.
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cost effectiveness of positive airway pressure modalities in Obesity Hypoventilation Syndrome with severe obstructive sleep apnoea
Thorax, 2020Co-Authors: Juan F Masa, Babak Mokhlesi, Ivan Benitez, Maria A Sanchezquiroga, Candela Caballero, Gomez De Terreros Caro Fj, A Romero, Maria Luz AlonsoalvarezAbstract:Background Obesity Hypoventilation Syndrome (OHS) is treated with either non-invasive ventilation (NIV) or CPAP, but there are no long-term cost-effectiveness studies comparing the two treatment modalities. Objectives We performed a large, multicentre, randomised, open-label controlled study to determine the comparative long-term cost and effectiveness of NIV versus CPAP in patients with OHS with severe obstructive sleep apnoea (OSA) using hospitalisation days as the primary outcome measure. Methods Hospital resource utilisation and within trial costs were evaluated against the difference in effectiveness based on the primary outcome (hospitalisation days/year, transformed and non-transformed in monetary term). Costs and effectiveness were estimated from a log-normal distribution using a Bayesian approach. A secondary analysis by adherence subgroups was performed. Results In total, 363 patients were selected, 215 were randomised and 202 were available for the analysis. The median (IQR) follow-up was 3.01 (2.91–3.14) years for NIV group and 3.00 (2.92–3.17) years for CPAP. The mean (SD) Bayesian estimated hospital days was 2.13 (0.73) for CPAP and 1.89 (0.78) for NIV. The mean (SD) Bayesian estimated cost per patient/year in the NIV arm, excluding hospitalisation costs, was €2075.98 (91.6), which was higher than the cost in the CPAP arm of €1219.06 (52.3); mean difference €857.6 (105.5). CPAP was more cost-effective than NIV (99.5% probability) because longer hospital stay in the CPAP arm was compensated for by its lower costs. Similar findings were observed in the high and low adherence subgroups. Conclusion CPAP is more cost-effective than NIV; therefore, CPAP should be the preferred treatment for patients with OHS with severe OSA. Trial registration number NCT01405976
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echocardiographic changes with positive airway pressure therapy in Obesity Hypoventilation Syndrome long term pickwick randomized controlled clinical trial
American Journal of Respiratory and Critical Care Medicine, 2020Co-Authors: Juan F Masa, Babak Mokhlesi, Ivan Benitez, Francisco Javier Gomez De Terreros, Maria A Sanchezquiroga, Auxiliadora Romero, Candela Caballeroeraso, Maria Luz Alonsoalvarez, Maria Victoria Mogollon, Estrella OrdaxcarbajoAbstract:Rationale: Obesity Hypoventilation Syndrome (OHS) has been associated with cardiac dysfunction. However, randomized trials assessing the impact of long-term noninvasive ventilation (NIV) or continu...
Juan F Masa - One of the best experts on this subject based on the ideXlab platform.
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cpap titration failure is not equivalent to long term cpap treatment failure in patients with Obesity Hypoventilation Syndrome a case series
Journal of Clinical Sleep Medicine, 2020Co-Authors: Alejandra Lastra, Juan F Masa, Babak MokhlesiAbstract:Study Objectives:Medium and long-term trials comparing continuous positive airway pressure (CPAP) with noninvasive ventilation in patients with Obesity Hypoventilation Syndrome have shown no differ...
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long term noninvasive ventilation in Obesity Hypoventilation Syndrome without severe osa the pickwick randomized controlled trial
Chest, 2020Co-Authors: Juan F Masa, Ivan Benitez, Francisco Javier Gomez De Terreros, Maria A Sanchezquiroga, Auxiliadora Romero, Candela Caballeroeraso, Jaime Corral, Maria Luz Alonsoalvarez, Estrella Ordaxcarbajo, Teresa GomezgarciaAbstract:Background Noninvasive ventilation (NIV) is an effective form of treatment in Obesity Hypoventilation Syndrome (OHS) with severe OSA. However, there is paucity of evidence in patients with OHS without severe OSA phenotype. Research Question Is NIV effective in OHS without severe OSA phenotype? Study Design and Methods In this multicenter, open-label parallel group clinical trial performed at 16 sites in Spain, we randomly assigned 98 stable ambulatory patients with untreated OHS and apnea-hypopnea index Results Forty-nine patients in the NIV group and 49 in the control group were randomized, and 48 patients in each group were analyzed. During a median follow-up of 4.98 years (interquartile range, 2.98-6.62), the mean hospitalization days per year ± SD was 2.60 ± 5.31 in the control group and 2.71 ± 4.52 in the NIV group (adjusted rate ratio, 1.07; 95% CI, 0.44-2.59; P = .882). NIV therapy, in contrast with the control group, produced significant longitudinal improvement in Paco2, pH, bicarbonate, quality of life (Medical Outcome Survey Short Form 36 physical component), and daytime sleepiness. Moreover, per-protocol analysis showed a statistically significant difference for the time until the first ED visit favoring NIV. In the subgroup with high NIV adherence, the time until the first event of hospital admission, ED visit, and mortality was longer than in the low adherence subgroup. Adverse events were similar between arms. Interpretation In stable ambulatory patients with OHS without severe OSA, NIV and lifestyle modification had similar long-term hospitalization days per year. A more intensive program aimed at improving NIV adherence may lead to better outcomes. Larger studies are necessary to better determine the long-term benefit of NIV in this subgroup of OHS. Trial Registry ClinicalTrials.gov; No.: NCT01405976; URL: www.clinicaltrials.gov ;
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weight loss interventions as treatment of Obesity Hypoventilation Syndrome a systematic review
Annals of the American Thoracic Society, 2020Co-Authors: Maximiliano Tamae Kakazu, Juan F Masa, Israa Soghier, Jan Brozek, Majid Afshar, Kevin C Wilson, Babak MokhlesiAbstract:Rationale: Obesity Hypoventilation Syndrome (OHS) is an undesirable consequence of Obesity. Weight loss is an important component of management based on clinical rationale, but the evidence supporting weight loss has not been summarized and the optimal approach has not been determined.Objectives: This systematic review informed an international, multidisciplinary panel of experts who had converged to develop a clinical practice guideline on OHS for the American Thoracic Society. The panel asked, "Should a weight loss intervention be performed in patients with OHS?"Methods: Medline, the Cochrane Library, and Embase were searched from January 1946 to March 2019 for studies that assessed weight loss interventions in obese adults with confirmed OHS, suspected OHS, or hypercapnia. The quality of the evidence was appraised using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach.Results: The search identified 2,994 articles. Six studies were selected, including two randomized trials and four nonrandomized studies without a comparator. Sample size ranged from 16 to 63 subjects. The studies found that a comprehensive weight loss program (including motivational counseling, dieting, and exercise) can reduce weight by 6% to 7% but confers no clinically significant effects compared with standard care. Bariatric surgery, on the other hand, is associated with more robust weight loss (15-64.6%, depending on the type of intervention), reduction of obstructive sleep apnea severity (18-44% reduction of the apnea-hypopnea index), and improvement in gas exchange (17-20% reduction in partial pressure of carbon dioxide in the arterial blood), ultimately leading to the resolution of OHS. Moreover, daytime sleepiness and pulmonary artery pressure also improve with significant weight loss. Bariatric surgery is associated with adverse effects in roughly one-fifth of patients, but serious adverse effects are very rare. The level of certainty in the estimated effects was very low for most outcomes.Conclusions: The guideline panel for which the systematic review was performed made a conditional (i.e., weak) recommendation suggesting a weight loss intervention for patients with OHS, targeting a sustained weight loss of 25% to 30% of actual body weight. This recommendation was based on very low-quality evidence. Although the weight loss target is based on the observation that greater weight loss is associated with better outcomes, there is a need for better-quality studies to ascertain the degree of weight loss necessary to achieve improvement in clinically relevant outcomes in patients with OHS.
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cost effectiveness of positive airway pressure modalities in Obesity Hypoventilation Syndrome with severe obstructive sleep apnoea
Thorax, 2020Co-Authors: Juan F Masa, Babak Mokhlesi, Ivan Benitez, Maria A Sanchezquiroga, Candela Caballero, Gomez De Terreros Caro Fj, A Romero, Maria Luz AlonsoalvarezAbstract:Background Obesity Hypoventilation Syndrome (OHS) is treated with either non-invasive ventilation (NIV) or CPAP, but there are no long-term cost-effectiveness studies comparing the two treatment modalities. Objectives We performed a large, multicentre, randomised, open-label controlled study to determine the comparative long-term cost and effectiveness of NIV versus CPAP in patients with OHS with severe obstructive sleep apnoea (OSA) using hospitalisation days as the primary outcome measure. Methods Hospital resource utilisation and within trial costs were evaluated against the difference in effectiveness based on the primary outcome (hospitalisation days/year, transformed and non-transformed in monetary term). Costs and effectiveness were estimated from a log-normal distribution using a Bayesian approach. A secondary analysis by adherence subgroups was performed. Results In total, 363 patients were selected, 215 were randomised and 202 were available for the analysis. The median (IQR) follow-up was 3.01 (2.91–3.14) years for NIV group and 3.00 (2.92–3.17) years for CPAP. The mean (SD) Bayesian estimated hospital days was 2.13 (0.73) for CPAP and 1.89 (0.78) for NIV. The mean (SD) Bayesian estimated cost per patient/year in the NIV arm, excluding hospitalisation costs, was €2075.98 (91.6), which was higher than the cost in the CPAP arm of €1219.06 (52.3); mean difference €857.6 (105.5). CPAP was more cost-effective than NIV (99.5% probability) because longer hospital stay in the CPAP arm was compensated for by its lower costs. Similar findings were observed in the high and low adherence subgroups. Conclusion CPAP is more cost-effective than NIV; therefore, CPAP should be the preferred treatment for patients with OHS with severe OSA. Trial registration number NCT01405976
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echocardiographic changes with positive airway pressure therapy in Obesity Hypoventilation Syndrome long term pickwick randomized controlled clinical trial
American Journal of Respiratory and Critical Care Medicine, 2020Co-Authors: Juan F Masa, Babak Mokhlesi, Ivan Benitez, Francisco Javier Gomez De Terreros, Maria A Sanchezquiroga, Auxiliadora Romero, Candela Caballeroeraso, Maria Luz Alonsoalvarez, Maria Victoria Mogollon, Estrella OrdaxcarbajoAbstract:Rationale: Obesity Hypoventilation Syndrome (OHS) has been associated with cardiac dysfunction. However, randomized trials assessing the impact of long-term noninvasive ventilation (NIV) or continu...
Amanda J Piper - One of the best experts on this subject based on the ideXlab platform.
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prevalence of chronic kidney disease in Obesity Hypoventilation Syndrome and obstructive sleep apnoea with severe Obesity
Sleep Medicine, 2020Co-Authors: Amanda J Piper, Sheila Sivam, Keith Wong, Brendon J Yee, David Wang, Steven J Chadban, Patrick J Hanly, Ronald R GrunsteinAbstract:Abstract Purpose Chronic kidney disease (CKD) is common in severe obstructive sleep apnoea (OSA), however prevalence in Obesity Hypoventilation Syndrome (OHS) is not known. This study sought to compare prevalence of CKD in OHS and equally obese OSA patients with comparable apnoea hypopnoea indexes (AHI), and secondarily examine the impact of positive airway pressure (PAP) therapy on CKD parameters. Methods Estimated Glomerular Filtration Rate (eGFR) and spot urine protein creatinine ratio (PCR) were obtained in patients with OHS (Partial pressure of carbon dioxide, PaCO2 > 45 mmHg) and OSA (AHI > 20 events per hour, PaCO2 40 kg/m2. Samples were obtained at baseline and after three months of PAP in both groups. Results Patients with OHS (n = 15, PaCO2 49 mmHg; daytime oxygen saturation, SpO2 94%; total sleep time with SpO2 0.5, p Conclusion The prevalence of CKD, primarily early-stage with proteinuria, is at least as frequent in OHS as it is in OSA, if not worse. Markers of CKD were not significantly impacted by PAP therapy.
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evaluation and management of Obesity Hypoventilation Syndrome an official american thoracic society clinical practice guideline
American Journal of Respiratory and Critical Care Medicine, 2019Co-Authors: Babak Mokhlesi, Juan F Masa, Amanda J Piper, Aiman Tulaimat, Patrick B Murphy, Jan Brozek, Majid Afshar, Indira Gurubhagavatula, Jay S Balachandran, Raed A DweikAbstract:Background: The purpose of this guideline is to optimize evaluation and management of patients with Obesity Hypoventilation Syndrome (OHS).Methods: A multidisciplinary panel identified and prioritized five clinical questions. The panel performed systematic reviews of available studies (up to July 2018) and followed the Grading of Recommendations, Assessment, Development, and Evaluation evidence-to-decision framework to develop recommendations. All panel members discussed and approved the recommendations.Recommendations: After considering the overall very low quality of the evidence, the panel made five conditional recommendations. We suggest that: 1) clinicians use a serum bicarbonate level <27 mmol/L to exclude the diagnosis of OHS in obese patients with sleep-disordered breathing when suspicion for OHS is not very high (<20%) but to measure arterial blood gases in patients strongly suspected of having OHS, 2) stable ambulatory patients with OHS receive positive airway pressure (PAP), 3) continuous positive airway pressure (CPAP) rather than noninvasive ventilation be offered as the first-line treatment to stable ambulatory patients with OHS and coexistent severe obstructive sleep apnea, 4) patients hospitalized with respiratory failure and suspected of having OHS be discharged with noninvasive ventilation until they undergo outpatient diagnostic procedures and PAP titration in the sleep laboratory (ideally within 2-3 mo), and 5) patients with OHS use weight-loss interventions that produce sustained weight loss of 25% to 30% of body weight to achieve resolution of OHS (which is more likely to be obtained with bariatric surgery).Conclusions: Clinicians may use these recommendations, on the basis of the best available evidence, to guide management and improve outcomes among patients with OHS.
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Obesity Hypoventilation Syndrome early detection of nocturnal only hypercapnia in an obese population
Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2018Co-Authors: Sheila Sivam, Keith Wong, Ronald R Grunstein, Brendon J Yee, David Wang, Amanda J PiperAbstract:STUDY OBJECTIVES Hypoventilation in Obesity is now divided into five stages; stage 0 (pure obstructive sleep apnea; OSA), stages I/II (Obesity-related sleep Hypoventilation; ORSH) and stages III/IV (awake hypercapnia, Obesity Hypoventilation Syndrome; OHS). Hypercapnia during the day may be preceded by Hypoventilation during sleep. The goal of this study was to determine the prevalence and to identify simple clinical measures that predict stages I/II ORSH. The effect of supine positioning on selected clinical measures was also evaluated. METHODS Ninety-four patients with a body mass index > 40 kg/m2 and a spirometric ratio > 0.7 were randomized to begin testing either in the supine or upright seated position on the day of their diagnostic sleep study. Arterialized capillary blood gases were measured in both positions. Oxygen saturation measured by pulse oximetry was also obtained while awake. Transcutaneous CO2 monitoring was performed during overnight polysomnography. RESULTS Stages I/II ORSH had a prevalence of 19% in an outpatient tertiary hospital setting compared with 61%, 17%, and 3% for stages 0, III/IV, and no sleep-disordered breathing respectively. Predictors for sleep Hypoventilation in this group were an awake oxygen saturation of ≤ 93% (sensitivity 39%, specificity 98%, positive likelihood ratio of 22) and a partial pressure of carbon dioxide ≥ 45 mmHg (sensitivity 44%, specificity 98%, positive likelihood ratio of 24) measured in the supine position. CONCLUSIONS ORSH has a similar prevalence to OHS. Awake oxygen saturation and partial pressure of carbon dioxide performed in the supine position may help predict obese patients with sleep Hypoventilation without awake hypercapnia. COMMENTARY A commentary on this article appears in this issue on page 1455. CLINICAL TRIAL REGISTRATION Registry: Australian New Zealand Clinical Trials Registry, Identifier: ACTRN 12615000135516, URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367493&isReview=true, Title: A cross-sectional study to identify obese patients who are at risk for developing Obesity Hypoventilation Syndrome (OHS) by investigating the relationship between daytime measures (including supine hypercapnia, distribution of body fat and lung volumes) with the presence of Hypoventilation during sleep.
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Obesity Hypoventilation Syndrome choosing the appropriate treatment of a heterogeneous disorder
Sleep Medicine Clinics, 2017Co-Authors: Ahmed S Bahammam, Amanda J Piper, Shahrokh JavaheriAbstract:The Obesity Hypoventilation Syndrome (OHS) is associated with significant morbidity and increased mortality compared with simple Obesity and eucapnic obstructive sleep apnea. Accurate diagnosis and commencement of early and appropriate management is fundamental in reducing the significant personal and societal burdens this disorder poses. Sleep disordered breathing is a major contributor to the developmental of sleep and awake hypercapnia, which characterizes OHS, and is effectively addressed through the use of positive airway pressure (PAP) therapy. This article reviews the current evidence supporting different modes of PAP currently used in managing these individuals.
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a randomised controlled trial of cpap versus non invasive ventilation for initial treatment of Obesity Hypoventilation Syndrome
Thorax, 2017Co-Authors: Mark E Howard, Amanda J Piper, Brendon J Yee, Daniel Flunt, Bronwyn Stevens, Anne E Holland, Eli Dabscheck, Duncan Mortimer, Angela T Burge, Catherine BuchanAbstract:Background Obesity Hypoventilation Syndrome (OHS) is the most common indication for home ventilation, although the optimal therapy remains unclear, particularly for severe disease. We compared Bi-level and continuous positive airways pressure (Bi-level positive airway pressure (PAP); CPAP) for treatment of severe OHS. Methods We conducted a multicentre, parallel, double-blind trial for initial treatment of OHS, with participants randomised to nocturnal Bi-level PAP or CPAP for 3 months. The primary outcome was frequency of treatment failure (hospital admission, persistent ventilatory failure or non-adherence); secondary outcomes included health-related quality of life (HRQoL) and sleepiness. Results Sixty participants were randomised; 57 completed follow-up and were included in analysis (mean age 53 years, body mass index 55 kg/m2, PaCO2 60 mm Hg). There was no difference in treatment failure between groups (Bi-level PAP, 14.8% vs CPAP, 13.3%, p=0.87). Treatment adherence and wake PaCO2 were similar after 3 months (5.3 hours/night Bi-level PAP, 5.0 hours/night CPAP, p=0.62; PaCO2 44.2 and 45.9 mm Hg, respectively, p=0.60). Between-group differences in improvement in sleepiness (Epworth Sleepiness Scale 0.3 (95% CI -2.8, 3.4), p=0.86) and HRQoL (Short Form (SF)36-SF6d 0.025 (95% CI -0.039, 0.088), p=0.45) were not significant. Baseline severity of ventilatory failure (PaCO2) was the only significant predictor of persistent ventilatory failure at 3 months (OR 2.3, p=0.03). Conclusions In newly diagnosed severe OHS, Bi-level PAP and CPAP resulted in similar improvements in ventilatory failure, HRQoL and adherence. Baseline PaCO2 predicted persistent ventilatory failure on treatment. Long-term studies are required to determine whether these treatments have different cost-effectiveness or impact on mortality. Trial registration number [ACTRN12611000874910][1], results. [1]: http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=343317&isReview=true
Auxiliadora Romero - One of the best experts on this subject based on the ideXlab platform.
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long term echocardiographic changes with positive airway pressure therapy in Obesity Hypoventilation Syndrome
European Respiratory Journal, 2020Co-Authors: Ma Angeles Sanchez Quiroga, Ivan Benitez, Francisco Javier Gomez De Terreros, Auxiliadora Romero, Maria Victoria Mogollon, Juan Fernando Masa Jimenez, Babak Mohklesi, Candela Caballero Eraso, Maria Luz Alonso Alvarez, Estrella Ordax CarballoAbstract:Rationale: Obesity Hypoventilation Syndrome (OHS) has been associated with cardiac dysfunction. However, randomized trials have assessing the impact of long-term noninvasive ventilation (NIV) or CPAP on cardiac structure and function assessed by echocardiography are lacking. Methods: In a pre-specified secondary analysis of the largest multicenter randomized controlled trial of OHS〔Pickwick project, n=221 patient with OHS and coexistent severe obstructive sleep apnea (OSA)〕, we compared the effectiveness of 3 years of NIV and CPAP on structural and functional echocardiographic changes. At baseline and annually during 3 sequential years patients underwent transthoracic two-dimensional and doppler echocardiography. Echocardiographers were blinded to the treatment allocation. Statistical analysis was performed using a linear mixed-effects model with a treatment group/repeated measures interaction to determine the differential effect between CPAP and NIV. Results:196 patients were analyzed, 102 treated with CPAP and 94 treated with NIV. Systolic pulmonary artery pressure decreased from 40.5±1.47 mmHg at baseline to 35.3±1.33 mmHg at 3 years with CPAP and from 41.5±1.56 mmHg to 35.5±1.42 with NIV (p Conclusion: In patients with OHS and concomitant severe OSA, long-term treatment with NIV and CPAP led to similar degrees of improvement in pulmonary hypertension and LVDF.
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long term noninvasive ventilation in Obesity Hypoventilation Syndrome without severe obstructive sleep apnoea
European Respiratory Journal, 2020Co-Authors: Ma Angeles Sanchez Quiroga, Ivan Benitez, Auxiliadora Romero, Jaime Corral, Estrella Ordax, Juan Fernando Masa Jimenez, Candela Caballero Eraso, Maria Luz Alonso Alvarez, Javier Gomez De Terreros, Teresa Gomez GarciaAbstract:Rationale: Noninvasive ventilation (NIV) is an effective treatment in Obesity Hypoventilation Syndrome (OHS) with severe obstructive sleep apnoea (OSA) but there is paucity of evidence in OHS patients without severe OSA phenotype. Methods: In this multicentre (16 sites in Spain), open-label parallel group clinical trial, we randomly assigned 98 stable ambulatory patients with untreated OHS and apnoea-hypopnoea index Results:49 patients were randomised in each group and 48 patients were analysed in each one of them. During a median [IQR] follow-up of 4.98 [2.98; 6.62] years, mean (SD) hospitalization days/year was 2.60 (5.31) in the control group and 2.71 (4.52) in the NIV group [adjusted rate ratio (95% CI) 1.07 (0.44; 2.59) (p = 0.882)]. Cardiovascular events occurred in 11 (23%) participants in the control group and 10 (21%) in the NIV group (hazard ratio (95% CI) 0.96 (0.40;2.30), p=0.927). Similar results were observed in the per-protocol analysis [rate ratio (95% CI) 1.21 (0.43;3.41) (p=0.717)]. Death occurred in 9 (19%) participants in both arms (adjusted hazard ratio (95% CI) 1.07 (0.41;2.82), p=0.893). Similar results were found in the per-protocol analysis [rate ratio (95% CI) 1.38 (0.50;3.79) (p=0.529)]. Conclusion: In stable ambulatory patients with OHS without severe OSA, NIV and lifestyle modification had similar long-term hospitalization days-year. Larger studies are necessary to better determine the long-term benefit of NIV in this subgroup of OHS.
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long term noninvasive ventilation in Obesity Hypoventilation Syndrome without severe osa the pickwick randomized controlled trial
Chest, 2020Co-Authors: Juan F Masa, Ivan Benitez, Francisco Javier Gomez De Terreros, Maria A Sanchezquiroga, Auxiliadora Romero, Candela Caballeroeraso, Jaime Corral, Maria Luz Alonsoalvarez, Estrella Ordaxcarbajo, Teresa GomezgarciaAbstract:Background Noninvasive ventilation (NIV) is an effective form of treatment in Obesity Hypoventilation Syndrome (OHS) with severe OSA. However, there is paucity of evidence in patients with OHS without severe OSA phenotype. Research Question Is NIV effective in OHS without severe OSA phenotype? Study Design and Methods In this multicenter, open-label parallel group clinical trial performed at 16 sites in Spain, we randomly assigned 98 stable ambulatory patients with untreated OHS and apnea-hypopnea index Results Forty-nine patients in the NIV group and 49 in the control group were randomized, and 48 patients in each group were analyzed. During a median follow-up of 4.98 years (interquartile range, 2.98-6.62), the mean hospitalization days per year ± SD was 2.60 ± 5.31 in the control group and 2.71 ± 4.52 in the NIV group (adjusted rate ratio, 1.07; 95% CI, 0.44-2.59; P = .882). NIV therapy, in contrast with the control group, produced significant longitudinal improvement in Paco2, pH, bicarbonate, quality of life (Medical Outcome Survey Short Form 36 physical component), and daytime sleepiness. Moreover, per-protocol analysis showed a statistically significant difference for the time until the first ED visit favoring NIV. In the subgroup with high NIV adherence, the time until the first event of hospital admission, ED visit, and mortality was longer than in the low adherence subgroup. Adverse events were similar between arms. Interpretation In stable ambulatory patients with OHS without severe OSA, NIV and lifestyle modification had similar long-term hospitalization days per year. A more intensive program aimed at improving NIV adherence may lead to better outcomes. Larger studies are necessary to better determine the long-term benefit of NIV in this subgroup of OHS. Trial Registry ClinicalTrials.gov; No.: NCT01405976; URL: www.clinicaltrials.gov ;
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echocardiographic changes with positive airway pressure therapy in Obesity Hypoventilation Syndrome long term pickwick randomized controlled clinical trial
American Journal of Respiratory and Critical Care Medicine, 2020Co-Authors: Juan F Masa, Babak Mokhlesi, Ivan Benitez, Francisco Javier Gomez De Terreros, Maria A Sanchezquiroga, Auxiliadora Romero, Candela Caballeroeraso, Maria Luz Alonsoalvarez, Maria Victoria Mogollon, Estrella OrdaxcarbajoAbstract:Rationale: Obesity Hypoventilation Syndrome (OHS) has been associated with cardiac dysfunction. However, randomized trials assessing the impact of long-term noninvasive ventilation (NIV) or continu...
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long term positive airway pressure therapy in Obesity Hypoventilation Syndrome cost study
European Respiratory Journal, 2019Co-Authors: Ma Angeles Sanchez Quiroga, Babak Mokhlesi, Ivan Benitez, Francisco Javier Gomez De Terreros, Auxiliadora Romero, Juan Fernando Masa Jimenez, Candela Caballero Eraso, Maria Luz Alonso Alvarez, Joaquin Teran Santos, Maria F TroncosoAbstract:Rationale: Obesity Hypoventilation Syndrome (OHS) is commonly treated with noninvasive ventilation (NIV) or CPAP. NIV is more complex and costly but provides ventilatory support. To date there have been no long-term or cost trials comparing these treatment modalities. Methods: We performed a large, randomized, multicenter, open-label controlled trial in Spain to compare the long-term effectiveness of NIV and CPAP using hospitalization days/year-patient as the primary end point. We carried out a simple cost analysis including effectiveness cost during 3 year of follow-up. We included the following cost groups: visits, adjustment of NIV, tests, medication, therapies and hospital resources utilization. A sensitivity analysis was conducted according to 3 different scenarios guided by the International Gross Domestic Product. Results: In total, 215 patients with untreated OHS and severe obstructive sleep apnea (OSA) were randomized to NIV or CPAP therapy and followed at least 3 years. The effectiveness was close between arms (mean difference NIV-CPAP: -0.19, 95% CI -1.13 to 0.75). The cost per patient/year was lower in the CPAP arm (1,898.2€; SD 1939.5) than the cost in the NIV arm (2,809.3€; SD 2901.6), mean difference -911.1€ (p Conclusions: In stable patients with OHS and severe OSA, despite NIV having a slight advantage in effectiveness, CPAP could be considered the first line of treatment due to its lower cost but, a case-by-case assessment is recommended to detect patients who would benefit from a switch to NIV.
Maria Luz Alonsoalvarez - One of the best experts on this subject based on the ideXlab platform.
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long term noninvasive ventilation in Obesity Hypoventilation Syndrome without severe osa the pickwick randomized controlled trial
Chest, 2020Co-Authors: Juan F Masa, Ivan Benitez, Francisco Javier Gomez De Terreros, Maria A Sanchezquiroga, Auxiliadora Romero, Candela Caballeroeraso, Jaime Corral, Maria Luz Alonsoalvarez, Estrella Ordaxcarbajo, Teresa GomezgarciaAbstract:Background Noninvasive ventilation (NIV) is an effective form of treatment in Obesity Hypoventilation Syndrome (OHS) with severe OSA. However, there is paucity of evidence in patients with OHS without severe OSA phenotype. Research Question Is NIV effective in OHS without severe OSA phenotype? Study Design and Methods In this multicenter, open-label parallel group clinical trial performed at 16 sites in Spain, we randomly assigned 98 stable ambulatory patients with untreated OHS and apnea-hypopnea index Results Forty-nine patients in the NIV group and 49 in the control group were randomized, and 48 patients in each group were analyzed. During a median follow-up of 4.98 years (interquartile range, 2.98-6.62), the mean hospitalization days per year ± SD was 2.60 ± 5.31 in the control group and 2.71 ± 4.52 in the NIV group (adjusted rate ratio, 1.07; 95% CI, 0.44-2.59; P = .882). NIV therapy, in contrast with the control group, produced significant longitudinal improvement in Paco2, pH, bicarbonate, quality of life (Medical Outcome Survey Short Form 36 physical component), and daytime sleepiness. Moreover, per-protocol analysis showed a statistically significant difference for the time until the first ED visit favoring NIV. In the subgroup with high NIV adherence, the time until the first event of hospital admission, ED visit, and mortality was longer than in the low adherence subgroup. Adverse events were similar between arms. Interpretation In stable ambulatory patients with OHS without severe OSA, NIV and lifestyle modification had similar long-term hospitalization days per year. A more intensive program aimed at improving NIV adherence may lead to better outcomes. Larger studies are necessary to better determine the long-term benefit of NIV in this subgroup of OHS. Trial Registry ClinicalTrials.gov; No.: NCT01405976; URL: www.clinicaltrials.gov ;
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cost effectiveness of positive airway pressure modalities in Obesity Hypoventilation Syndrome with severe obstructive sleep apnoea
Thorax, 2020Co-Authors: Juan F Masa, Babak Mokhlesi, Ivan Benitez, Maria A Sanchezquiroga, Candela Caballero, Gomez De Terreros Caro Fj, A Romero, Maria Luz AlonsoalvarezAbstract:Background Obesity Hypoventilation Syndrome (OHS) is treated with either non-invasive ventilation (NIV) or CPAP, but there are no long-term cost-effectiveness studies comparing the two treatment modalities. Objectives We performed a large, multicentre, randomised, open-label controlled study to determine the comparative long-term cost and effectiveness of NIV versus CPAP in patients with OHS with severe obstructive sleep apnoea (OSA) using hospitalisation days as the primary outcome measure. Methods Hospital resource utilisation and within trial costs were evaluated against the difference in effectiveness based on the primary outcome (hospitalisation days/year, transformed and non-transformed in monetary term). Costs and effectiveness were estimated from a log-normal distribution using a Bayesian approach. A secondary analysis by adherence subgroups was performed. Results In total, 363 patients were selected, 215 were randomised and 202 were available for the analysis. The median (IQR) follow-up was 3.01 (2.91–3.14) years for NIV group and 3.00 (2.92–3.17) years for CPAP. The mean (SD) Bayesian estimated hospital days was 2.13 (0.73) for CPAP and 1.89 (0.78) for NIV. The mean (SD) Bayesian estimated cost per patient/year in the NIV arm, excluding hospitalisation costs, was €2075.98 (91.6), which was higher than the cost in the CPAP arm of €1219.06 (52.3); mean difference €857.6 (105.5). CPAP was more cost-effective than NIV (99.5% probability) because longer hospital stay in the CPAP arm was compensated for by its lower costs. Similar findings were observed in the high and low adherence subgroups. Conclusion CPAP is more cost-effective than NIV; therefore, CPAP should be the preferred treatment for patients with OHS with severe OSA. Trial registration number NCT01405976
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echocardiographic changes with positive airway pressure therapy in Obesity Hypoventilation Syndrome long term pickwick randomized controlled clinical trial
American Journal of Respiratory and Critical Care Medicine, 2020Co-Authors: Juan F Masa, Babak Mokhlesi, Ivan Benitez, Francisco Javier Gomez De Terreros, Maria A Sanchezquiroga, Auxiliadora Romero, Candela Caballeroeraso, Maria Luz Alonsoalvarez, Maria Victoria Mogollon, Estrella OrdaxcarbajoAbstract:Rationale: Obesity Hypoventilation Syndrome (OHS) has been associated with cardiac dysfunction. However, randomized trials assessing the impact of long-term noninvasive ventilation (NIV) or continu...
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echocardiographic changes with non invasive ventilation and cpap in Obesity Hypoventilation Syndrome
Thorax, 2018Co-Authors: Jaime Corral, Maria A Sanchezquiroga, Auxiliadora Romero, Joaquin Teransantos, Candela Caballero, Maria Luz Alonsoalvarez, Teresa Gomezgarcia, Maria Victoria Mogollon, Javier Gomez De Terreros, Monica GonzalezAbstract:Rationale Despite a significant association between Obesity Hypoventilation Syndrome (OHS) and cardiac dysfunction, no randomised trials have assessed the impact of non-invasive ventilation (NIV) or CPAP on cardiac structure and function assessed by echocardiography. Objectives We performed a secondary analysis of the data from the largest multicentre randomised controlled trial of OHS (Pickwick project, n=221) to determine the comparative efficacy of 2 months of NIV (n=71), CPAP (n=80) and lifestyle modification (control group, n=70) on structural and functional echocardiographic changes. Methods Conventional transthoracic two-dimensional and Doppler echocardiograms were obtained at baseline and after 2 months. Echocardiographers at each site were blinded to the treatment arms. Statistical analysis was performed using intention-to-treat analysis. Results At baseline, 55% of patients had pulmonary hypertension and 51% had evidence of left ventricular hypertrophy. Treatment with NIV, but not CPAP, lowered systolic pulmonary artery pressure (−3.4 mm Hg, 95% CI −5.3 to –1.5; adjusted P=0.025 vs control and P=0.033 vs CPAP). The degree of improvement in systolic pulmonary artery pressure was greater in patients treated with NIV who had pulmonary hypertension at baseline (−6.4 mm Hg, 95% CI −9 to –3.8). Only NIV therapy decreased left ventricular hypertrophy with a significant reduction in left ventricular mass index (−5.7 g/m 2 ; 95% CI −11.0 to –4.4). After adjusted analysis, NIV was superior to control group in improving left ventricular mass index (P=0.015). Only treatment with NIV led to a significant improvement in 6 min walk distance (32 m; 95% CI 19 to 46). Conclusion In patients with OHS, medium-term treatment with NIV is more effective than CPAP and lifestyle modification in improving pulmonary hypertension, left ventricular hypertrophy and functional outcomes. Long-term studies are needed to confirm these results. Trial registration number Pre-results, NCT01405976 (https://clinicaltrials.gov/).
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echocardiographic changes with positive airway pressure in Obesity Hypoventilation Syndrome pickwick study
European Respiratory Journal, 2017Co-Authors: Ma Angeles Sanchez Quiroga, Francisco Javier Gomez De Terreros, Auxiliadora Romero, Joaquin Teransantos, Jaime Corral, Candela Caballero, Maria Luz Alonsoalvarez, Teresa Gomezgarcia, Maria Victoria Mogollon, Monica GonzalezAbstract:There are no randomized controlled trials assessing the impact of noninvasive ventilation (NIV) and continuous positive airway pressure (CPAP) on cardiac function in Obesity Hypoventilation Syndrome (OHS). Objective: To determine the efficacy of 2 months of NIV, CPAP or lifestyle modification (control) on echocardiographic changes. Method: OHS patients (n=302) were sequentially randomized by: 1) severe obstructive sleep apnea (OSA), into NIV, CPAP or control; 2) non-severe OSA, into NIV or control. ABG, spirometry, six-minute walk distance, Epworth sleepiness scale, polysomnography and transthoracic echocardiogram were evaluated. Results: We analyzed 2 groups: 1) with or without severe OSA and NIV or control treatments (entire OHS group; n=222); 2) with severe OSA and NIV, CPAP or control treatments (severe OSA subgroup; n=221). In the entire OHS group, NIV improved the left ventricular (LV) hypertrophy (mass index: -6.6 g/m2; 95%CI -11/-2.1 vs 3.6; 95%CI -1.1/8.3; adjusted p Conclusion: Medium-term NIV therapy is more effective than CPAP and lifestyle modification in improving PAP and LV hypertrophy in OHS
